Description of Event or Problem · 0
HERE IS A FORMAL COMPLAINT LETTER TO THE FOOD AND DRUG ADMINISTRATION (FDA) REGARDING THE TUMAKOU HIGH-FREQUENCY FACIAL MACHINE CAUSING BURNS AND LACKING FDA APPROVAL: SUBJECT: URGENT SAFETY CONCERN ¿ HIGH-FREQUENCY FACIAL MACHINE CAUSING BURNS (ASIN:B07YXQW4H1) DEAR FOOD AND DRUG ADMINISTRATION (FDA) COMPLIANCE TEAM, I AM WRITING TO FORMALLY REPORT A SAFETY ISSUE REGARDING THE TUMAKOU HIGH-FREQUENCY FACIAL MACHINE, SOLD ON AMAZON UNDER ASIN B07YXQW4H1 (PRODUCT LINK). 1. SEVERE BURN INJURY FROM PRODUCT USAGE AFTER USING THIS PRODUCT AS INSTRUCTED, I EXPERIENCED PAINFUL BURNS ON MY SKIN. I FOLLOWED THE GUIDELINES PROVIDED BY THE MANUFACTURER AND DID NOT EXCEED THE RECOMMENDED USAGE TIME, YET THE DEVICE CAUSED VISIBLE BURNS AND IRRITATION. 2. FALSE FOOD AND DRUG ADMINISTRATION (FDA) COMPLIANCE CLAIM UPON REVIEWING THE FOOD AND DRUG ADMINISTRATION (FDA) 510(K) DATABASE, I FOUND THAT THIS PRODUCT DOES NOT HAVE FDA CLEARANCE OR APPROVAL. HOWEVER, THE SELLER MISLEADINGLY IMPLIES FOOD AND DRUG ADMINISTRATION (FDA) COMPLIANCE ON THE PRODUCT LISTING. THIS RAISES SERIOUS CONCERNS REGARDING CONSUMER SAFETY AND REGULATORY VIOLATIONS. 3. REQUEST FOR FOOD AND DRUG ADMINISTRATION (FDA) INVESTIGATION GIVEN THE POTENTIAL HARM THIS PRODUCT POSES TO CONSUMERS, I URGE THE FOOD AND DRUG ADMINISTRATION (FDA) TO: INVESTIGATE THE MANUFACTURER'S CLAIMS REGARDING FOOD AND DRUG ADMINISTRATION (FDA) APPROVAL. ASSESS THE PRODUCT'S SAFETY DUE TO MULTIPLE REPORTS OF BURNS AND INJURIES. TAKE APPROPRIATE ENFORCEMENT ACTIONS IF THE PRODUCT IS FOUND TO BE NONCOMPLIANT WITH FOOD AND DRUG ADMINISTRATION (FDA) REGULATIONS. I APPRECIATE YOUR ATTENTION TO THIS MATTER AND LOOK FORWARD TO YOUR RESPONSE. PLEASE LET ME KNOW IF YOU REQUIRE ADDITIONAL INFORMATION.